Trial Outcomes & Findings for Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001) (NCT NCT01215110)
NCT ID: NCT01215110
Last Updated: 2017-04-26
Results Overview
The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Fourteen consecutive days of treatment
Results posted on
2017-04-26
Participant Flow
Participant milestones
| Measure |
TMC207 100
TMC207- 200 mg Day 1; and 100 mg Days 2-14
|
TMC207 200
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
|
TMC207 300
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
|
TMC207 400
TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
|
Rifafour e-275 mg
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
8
|
|
Overall Study
COMPLETED
|
15
|
15
|
13
|
14
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
Baseline characteristics by cohort
| Measure |
TMC207 100
n=15 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=15 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=15 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 18.1 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
26.1 years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
27 years
STANDARD_DEVIATION 11.45 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
33 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Mixed Ethnic
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
2 participants
n=21 Participants
|
35 participants
n=8 Participants
|
|
Height
|
1.638 meters (m)
STANDARD_DEVIATION 0.082 • n=5 Participants
|
1.677 meters (m)
STANDARD_DEVIATION 0.094 • n=7 Participants
|
1.674 meters (m)
STANDARD_DEVIATION 0.082 • n=5 Participants
|
1.660 meters (m)
STANDARD_DEVIATION 0.057 • n=4 Participants
|
1.660 meters (m)
STANDARD_DEVIATION 0.087 • n=21 Participants
|
1.662 meters (m)
STANDARD_DEVIATION 0.080 • n=8 Participants
|
|
Weight at Day 1
|
53.0 kilograms (kg)
STANDARD_DEVIATION 7.74 • n=5 Participants
|
52.5 kilograms (kg)
STANDARD_DEVIATION 7.55 • n=7 Participants
|
52.7 kilograms (kg)
STANDARD_DEVIATION 8.20 • n=5 Participants
|
50.6 kilograms (kg)
STANDARD_DEVIATION 5.96 • n=4 Participants
|
49.1 kilograms (kg)
STANDARD_DEVIATION 6.69 • n=21 Participants
|
51.8 kilograms (kg)
STANDARD_DEVIATION 7.23 • n=8 Participants
|
|
Body Mass Index (BMI)
|
19.80 kg/m^2
STANDARD_DEVIATION 2.988 • n=5 Participants
|
18.63 kg/m^2
STANDARD_DEVIATION 1.955 • n=7 Participants
|
18.80 kg/m^2
STANDARD_DEVIATION 2.754 • n=5 Participants
|
18.36 kg/m^2
STANDARD_DEVIATION 2.174 • n=4 Participants
|
17.83 kg/m^2
STANDARD_DEVIATION 2.018 • n=21 Participants
|
18.77 kg/m^2
STANDARD_DEVIATION 2.459 • n=8 Participants
|
|
HIV Status
Positive
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
6 participants
n=8 Participants
|
|
HIV Status
Negative
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
13 participants
n=4 Participants
|
7 participants
n=21 Participants
|
62 participants
n=8 Participants
|
|
Baseline log10 colony forming units (CFU) of M. Tuberculosis per ml sputum
|
6.302 log(10) CFU/ml
STANDARD_DEVIATION 0.697 • n=5 Participants
|
6.001 log(10) CFU/ml
STANDARD_DEVIATION 0.903 • n=7 Participants
|
6.071 log(10) CFU/ml
STANDARD_DEVIATION 1.087 • n=5 Participants
|
6.625 log(10) CFU/ml
STANDARD_DEVIATION 0.756 • n=4 Participants
|
5.995 log(10) CFU/ml
STANDARD_DEVIATION 1.018 • n=21 Participants
|
6.199 log(10) CFU/ml
STANDARD_DEVIATION 0.892 • n=8 Participants
|
|
Baseline time to sputum culture positivity (TTP) in liquid culture media
|
104.8 hours
STANDARD_DEVIATION 23.5 • n=5 Participants
|
111.1 hours
STANDARD_DEVIATION 30.6 • n=7 Participants
|
115.7 hours
STANDARD_DEVIATION 40.8 • n=5 Participants
|
88.5 hours
STANDARD_DEVIATION 10.8 • n=4 Participants
|
106.7 hours
STANDARD_DEVIATION 28.8 • n=21 Participants
|
105.3 hours
STANDARD_DEVIATION 26.9 • n=8 Participants
|
PRIMARY outcome
Timeframe: Fourteen consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.
The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.
Outcome measures
| Measure |
TMC207 100
n=14 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=14 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).
|
0.040 log10CFU/ml/day
Standard Deviation 0.068
|
0.056 log10CFU/ml/day
Standard Deviation 0.051
|
0.077 log10CFU/ml/day
Standard Deviation 0.064
|
0.104 log10CFU/ml/day
Standard Deviation 0.077
|
0.112 log10CFU/ml/day
Standard Deviation 0.077
|
SECONDARY outcome
Timeframe: Days 7-14 of fourteen consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.
The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since Day 7 is later than the node day, the rate of change for this outcome is equal to the slope at Day 14. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.
Outcome measures
| Measure |
TMC207 100
n=14 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=14 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).
|
0.053 log10CFU/ml/day
Standard Deviation 0.088
|
0.086 log10CFU/ml/day
Standard Deviation 0.048
|
0.098 log10CFU/ml/day
Standard Deviation 0.084
|
0.107 log10CFU/ml/day
Standard Deviation 0.082
|
0.046 log10CFU/ml/day
Standard Deviation 0.101
|
SECONDARY outcome
Timeframe: Days 2-14 of fourteen consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.
The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.
Outcome measures
| Measure |
TMC207 100
n=14 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=14 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).
|
0.047 log10CFU/ml/day
Standard Deviation 0.074
|
0.071 log10CFU/ml/day
Standard Deviation 0.047
|
0.088 log10CFU/ml/day
Standard Deviation 0.071
|
0.106 log10CFU/ml/day
Standard Deviation 0.078
|
0.046 log10CFU/ml/day
Standard Deviation 0.101
|
SECONDARY outcome
Timeframe: Two consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.
The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since this range (Days0-2) is before the node day, the rate of change for this outcome is equal to the slope at Day 0. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.
Outcome measures
| Measure |
TMC207 100
n=14 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=14 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).
|
0.004 log10CFU/ml/day
Standard Deviation 0.168
|
-0.033 log10CFU/ml/day
Standard Deviation 0.128
|
0.015 log10CFU/ml/day
Standard Deviation 0.149
|
0.093 log10CFU/ml/day
Standard Deviation 0.136
|
0.413 log10CFU/ml/day
Standard Deviation 0.291
|
SECONDARY outcome
Timeframe: Fourteen consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.
The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.
Outcome measures
| Measure |
TMC207 100
n=13 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=13 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=12 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)
|
4.0 hours/day
Standard Deviation 5.1
|
4.2 hours/day
Standard Deviation 3.1
|
4.9 hours/day
Standard Deviation 5.1
|
5.4 hours/day
Standard Deviation 3.4
|
14.3 hours/day
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Two consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.
The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.
Outcome measures
| Measure |
TMC207 100
n=13 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=13 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=12 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2)
|
1.5 hours/day
Standard Deviation 2.3
|
3.7 hours/day
Standard Deviation 4.3
|
4.1 hours/day
Standard Deviation 4.7
|
6.2 hours/day
Standard Deviation 3.3
|
27.3 hours/day
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Days 2-14 of fourteen consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.
The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.
Outcome measures
| Measure |
TMC207 100
n=13 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=13 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=12 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14)
|
4.4 hours/day
Standard Deviation 5.9
|
4.3 hours/day
Standard Deviation 3.1
|
5.1 hours/day
Standard Deviation 5.3
|
5.3 hours/day
Standard Deviation 3.5
|
11.5 hours/day
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Days 7-14 of fourteen consecutive days of treatmentPopulation: Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.
The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.
Outcome measures
| Measure |
TMC207 100
n=13 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=13 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=13 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=12 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 Participants
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 7-14)
|
6.9 hours/day
Standard Deviation 11.2
|
4.8 hours/day
Standard Deviation 4.4
|
5.9 hours/day
Standard Deviation 7.2
|
4.4 hours/day
Standard Deviation 5.0
|
11.5 hours/day
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)Population: On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants
Outcome measures
| Measure |
TMC207 100
n=15 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=15 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=15 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Summary of Statistical Analysis of TMC207 Maximum Plasma Concentration Following Dosing (C(Max)) on Days 1 and 14
C(max) Day 1
|
1846.13 ng/mL
Standard Deviation 613.55
|
2700.73 ng/mL
Standard Deviation 858.54
|
3128.00 ng/mL
Standard Deviation 1239.26
|
5386.67 ng/mL
Standard Deviation 3069.95
|
—
|
|
Summary of Statistical Analysis of TMC207 Maximum Plasma Concentration Following Dosing (C(Max)) on Days 1 and 14
C(max) Day 14
|
1553.27 ng/mL
Standard Deviation 691.36
|
2884.67 ng/mL
Standard Deviation 789.44
|
3902.31 ng/mL
Standard Deviation 771.77
|
5178.57 ng/mL
Standard Deviation 2663.75
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)Population: On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants
Outcome measures
| Measure |
TMC207 100
n=15 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=15 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=15 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Summary of Statistical Analysis of TMC207 Time of Maximum Plasma Concentration (T(Max)) on Days 1 and 14
T(max) Day 1
|
5.33 hour
Standard Deviation 1.80
|
5.20 hour
Standard Deviation 1.90
|
5.53 hour
Standard Deviation 0.83
|
5.67 hour
Standard Deviation 1.05
|
—
|
|
Summary of Statistical Analysis of TMC207 Time of Maximum Plasma Concentration (T(Max)) on Days 1 and 14
T(max) Day 14
|
5.13 hour
Standard Deviation 1.19
|
4.60 hour
Standard Deviation 1.06
|
5.15 hour
Standard Deviation 1.46
|
5.29 hour
Standard Deviation 1.59
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose)Population: On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants
Outcome measures
| Measure |
TMC207 100
n=15 Participants
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 Participants
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=15 Participants
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=15 Participants
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Summary of Statistical Analysis of TMC207 Area Under the Concentration-time Curve Over the Dose Interval of 0 to 24 h (AUC(0-24)) on Day 1 and Day 14
AUC(0-24) Day 1
|
18995.57 ng*h/mL
Standard Deviation 6947.92
|
26619.51 ng*h/mL
Standard Deviation 8453.09
|
31357.35 ng*h/mL
Standard Deviation 10596.74
|
53179.27 ng*h/mL
Standard Deviation 20699.64
|
—
|
|
Summary of Statistical Analysis of TMC207 Area Under the Concentration-time Curve Over the Dose Interval of 0 to 24 h (AUC(0-24)) on Day 1 and Day 14
AUC(0-24) Day 14
|
18689.03 ng*h/mL
Standard Deviation 4450.56
|
33314.07 ng*h/mL
Standard Deviation 5780.02
|
50547.15 ng*h/mL
Standard Deviation 11914.16
|
69069.64 ng*h/mL
Standard Deviation 27062.36
|
—
|
Adverse Events
TMC207 100
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TMC207 200
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TMC207 300
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TMC207 400
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Rifafour e-275 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TMC207 100
n=15 participants at risk
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 participants at risk
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=15 participants at risk
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=15 participants at risk
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 participants at risk
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
Other adverse events
| Measure |
TMC207 100
n=15 participants at risk
TMC207- 200 mg Day 1 and 100 mg Days 2-14
|
TMC207 200
n=15 participants at risk
TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
|
TMC207 300
n=15 participants at risk
TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
|
TMC207 400
n=15 participants at risk
TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
|
Rifafour e-275 mg
n=8 participants at risk
Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
|
|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Investigations
Weight decreased
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Infections and infestations
Body tinea
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
12.5%
1/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
13.3%
2/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
25.0%
2/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
6.7%
1/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/15 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
0.00%
0/8 • 49 days
Adverse events were collected by the Investigator from the time a participant signed the Informed Consent Form until the end of follow-up visit (Day 49). Data reported are treatment-emergent adverse events.
|
Additional Information
Daniel E. Everitt, MD, Vice President and Senior Medical Officer
Global Alliance for TB Drug Development
Phone: 212-227-7540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator or any Sub-Investigator shall submit any oral or written publication or abstract concerning this study to the Sponsor not less than thirty (30) days prior to submission to any journal, other publication or meeting, for review and removal of confidential information.
- Publication restrictions are in place
Restriction type: OTHER